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Cardiovascular

Apple COPD - Closed

Anti-platelet Therapy in the Primary Prevention of CardiovascuLar DisEase in Patients with Chronic Obstructive Pulmonary Disease

  • Status: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: Astra Zeneca
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: To investigate if treatment with antiplatelet therapy (APT) will produce a response in platelet function measured using the Multiplate test in patients with chronic obstructive pulmonary disease (COPD).

Primary Outcome:

Inhibition of ASPI and ADP-induced platelet aggregation at 6-month

  • Population: Adult
  • Design: RCT
  • Setting: Secondary Care
  • Planned Sample Size: 120

CAPRI - Closed

Evaluating the effectiveness of intravenous ciclosporin on reducing reperfusion injury in patients undergoing primary percutaneous coronary intervention: a double-blind, phase II, randomised controlled trial

  • Status: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR Biomedical Research Centre (BRC)
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: To determine the effect of ciclosporin treatment prior to PPCI on infarct size at 12 weeks relative to placebo treatment.

Primary Outcome:  Infarct size at 12 weeks post-PPCI as measured by cardiac magnetic resonance imaging (MRI). Infarct size will be calculated as the percent of infarcted myocardium per LV mass.

  • Clinical Phase: IIb
  • Population: Adult
  • Design: RCT
  • Setting: Emergency Care
  • Planned Sample Size: 68

CONFORM-OH - Closedown/Analysis

Control, Fludrocortisone or Midodrine for the treatment of Orthostatic Hypotension: A Randomised Controlled Trial

  • Status: Closedown/Analysis
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: This trial will evaluate the clinical and cost effectiveness of three different treatment strategies for orthostatic hypotension.

Primary outcome:

To determine whether the treatment strategies of conservative management plus fludrocortisone, and conservative management plus midodrine improve symptoms of OH compared to conservative management alone.

  • Clinical Phase: IV
  • Population: Adults
  • Design: RCT Adaptive
  • Setting: Secondary Care
  • Planned Sample Size: 366

DMD-Heart - Closed

A double-blind randomised multi-centre, placebo-controlled trial of combined ACE-inhibitor and beta-blocker therapy in preventing the development of cardiomyopathy in genetically characterised males with DMD without echo-detectable left ventricular dysfunction

  • Status: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: British Heart Foundation
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: Determine whether the introduction of ACE-inhibitor combined with beta-blocker therapy, before the onset of echo-detectable left ventricular dysfunction, can delay the age of onset and/or slow the rate of progression of cardiomyopathy compared to placebo in males with DMD.

Primary Outcome:
Change in left ventricular ejection fraction (LVEF %), compared to baseline after a minimum of three years of combination therapy or placebo.
To assess the robustness of ejection fraction result, similar comparisons will be made for parameters of left ventricular end-systolic dimension, wall motion index and left ventricular fractional shortening (%) and mitral flow to left ventricular tissue Doppler ratios (E/E’ ratios)

  • Clinical Phase: III
  • Population: Paediatrics (males)
  • Design: RCT
  • Setting: Secondary Care
  • Planned Sample Size: 140

FRACTAL - In Follow-up

A phase IIa, randomized, 2-arm parallel-group, placebo-controlled, double-blind, multi-centre trial to evaluate safety, tolerability, anti-inflammatory and cardio- protective effects after intravenous and oral administration of KAND567 in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention.

  • Study stage: In follow-up
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: Kancera AB, Solna, Sweden
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: To determine the safety and tolerability following intravenous and oral administration of KAND567 in ST-Elevation Myocardial Infarction (STEMI) patients undergoing PCI.

Primary Outcome:  The safety and tolerability of KAND567 relative to placebo will be assessed on the following:

 Occurrence of adverse events (AEs) during 3 months trial participation
 Changes in vital signs between baseline and 3 months
 Safety bloods including blood chemistry, haematology and urinalysis. See table 8.1. These are compared with baseline values.

  • Clinical Phase: IIa
  • Population: Adults
  • Design: Randomised Control Trial (RCT)
  • Setting: Emergency Care
  • Planned Sample Size: 60

PrEPS - Closed

PrEPS - Prehabilitation in Elective Patients Undergoing Cardiac Surgery: A Randomised Controlled Trial

  • Status: Closed
  • Sponsor: South Tees NHS Hospitals Foundation Trust
  • Funder: Heart Research UK
  • Therapeutic area: Cardiovascular
  • Type of study: Clinical Intervention

Aim: The overarching research aim is to assess the impact of a pre-operative rehabilitation intervention (prehabilitation) on pre- operative physical, functional and clinical outcomes in adult patients awaiting cardiac surgery.

Primary outcome:

Change in 6MWT from baseline to post intervention compared to those receiving standard care over the same period.

  • Population: Adults
  • Design: RCT
  • Setting: Secondary Care
  • Planned Sample Size: 182

PROACT - In Follow-up

PROACT - Preventing cardiac damage in patients treated for breast cancer and lymphoma: a phase 3 Randomised, Open label, blinded endpoint, superiority trial of enalapril to prevent Anthracycline-induced CardioToxicity

  • Status: In follow-up
  • Sponsor: South Tees NHS Hospitals Foundation Trust
  • Funder: NIHR RfPB
  • Therapeutic area: Cardiovascular and Cancer
  • Type of study: CTIMP

Aim: Can the ACEi Enalapril prevent anthracycline-induced cardiotoxicity in patient treated for breast cancer or Non Hodgkin lymphoma.

Primary outcome: The presence (≥14ng/L) or absence of cardiac troponin T (<14ng/L) release at any time during anthracycline treatment, and one month after the last dose of anthracycline.

  • Clinical Phase: III
  • Population: Adults
  • Design: RCT
  • Setting: Secondary Care
  • Planned Sample Size: 170

Senior Rita - Recruiting

The British Heart Foundation older patients with non-ST SEgmeNt elevation myocaRdial infarction Randomized Interventional TreAtment Trial

  • Status: Recruiting
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: British Heart Foundation
  • Therapeutic area: Cardiovascular
  • Type of study: Surgical

Aim: SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting with type 1 NSTEMI (Non ST elevation myocardial infarction) aged ≥75 years between invasive and conservative treatment strategies, to compare time to cardiovascular death or non-fatal MI (myocardial infarction) within one year from randomization.

Primary outcome:

Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition).

  • Population: Adults
  • Design: Randomised Control Trial (RCT)
  • Setting: Secondary Care
  • Planned Sample Size: 1668

Website: https://research.ncl.ac.uk/seniorrita/

TACTIC - Closed

Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome: a double-blind, phase II, pilot randomised controlled trial (TACTIC).

  • Study stage: Closedown/Analysis
  • Sponsor: South Tees NHS Hospitals Foundation Trust
  • Funder: Investigator-Initiated, non-commercial, commercially funded trial. Funding from: TA. Sciences, New York, USA
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: The main purpose of the TACTIC study is to see whether TA-65MD® treatment for 1 year increases the length of the protective telomeres, and whether this leads to fewer ‘aged’ CD8 T cells (cells with shorter telomeres) in patients who have coronary heart disease. This study will also investigate the effect of TA-65MD® on the small blood vessels that play an important role in cardiovascular health.

Primary outcome:  To assess the effect of 1-year TA-65MD® treatment on immunosenescence in older patients following acute coronary syndrome (ACS).

  • Population: Adults
  • Clinical Phase: II
  • Design: RCT
  • Setting: Secondary Care
  • Planned Sample Size: 90

ThyrAMI - Closed

THYRoxine in Acute Myocardial Infarction (ThyrAMI)

  • Study stage: Closed
  • Sponsor: Gateshead Health NHS Foundation Trust
  • Funder:  NIHR Fellowship
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: To assess what proportion of individuals with AMI have thyroid dysfunction and whether thyroid function at the time of AMI is related to adverse vascular outcomes.

Primary Outcome:

The association between thyroid status at the time of AMI (within 24 hours of diagnosis) with vascular outcomes (another AMI, coronary revascularisation or death due to ischaemic heart disease) over 24 months.

  • Clinical Phase: IIII
  • Population: Adults
  • Design: Randomised Control Trial (RCT)
  • Setting: Secondary Care
  • Planned Sample Size: 100

UK Mini Mitral - Closedown/Analysis

UK Mini Mitral - Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial

  • Study stage: Closedown/Analysis
  • Sponsor: South Tees NHS Hospitals Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Cardiovascular
  • Type of study: Surgical

Aim: To determine if physical functioning and associated return to usual activities improves in patients who undergo mitral valve repair via minimally invasive thoracoscopically-guided right minithoracotomy compared to conventional sternotomy at 12 weeks.

Primary outcome:  Change in SF-36v2 physical functioning scale (1) at 12 weeks following surgery.

Primary economic outcome: incremental cost per QALY gained at 52 weeks following surgery.

  • Population: Adults
  • Design: Randomised Control Trial (RCT)
  • Setting: Secondary Care
  • Planned Sample Size: 316

Website: https://heartvalvevoice.com/news/news/uk-mini-mitral-trial

Protect - In Set-up

Optimum therapy for thromboembolic complications after mitral valve repair

  • Study stage: Set-up
  • Sponsor: South Tees Hospital
  • Funder:  NIHR HTA
  • Therapeutic area: Cardiovascular
  • Type of study:  Surgical

E-CLAD UK - Recruiting

Extracorporeal Photophoresis in the treatment of Chronic Lung Allograft Dysfunction: a randomised controlled trial (E-CLAD UK).

  • Study stage: Recruiting
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder:  NIHR EME
  • Therapeutic area: Cardiovascular
  • Type of study: CTIMP

Aim: To determine if extracorporeal photopheresis (ECP) therapy plus standard of care (SOC) is more effective at improving or stabilising lung function in lung transplant recipients with chronic lung allograft dysfunction (CLAD) compared to SOC alone

Primary Outcome: Composite responder outcome of lung function stabilisation derived from change in Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC) at 12 and 24 weeks compared to baseline at study entry.

  • Clinical Phase: II
  • Population: Adults
  • Design: RCT (open label)
  • Setting: Secondary Care
  • Planned Sample Size: 90
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