A Pilot Feasibility Study in Recovered Heart Failure

Heart Failure Clinical Trial

— TRED  

Official title:

A Pilot Feasibility Study in Recovered Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02859311
• Other study ID #: 2015CD007B
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 14, 2016
• Last updated: November 8, 2017
• Start date: April 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2017
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. These patients have an excellent long-term prognosis. Whether they need to remain on long-term medical therapy is not clear. The investigators will investigate the safety of therapy withdrawal in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial.

Description:

Patients with a previous diagnosis of heart failure, who have recovered cardiac function, without symptoms, normal serum biomarker concentrations and who are currently still taking heart failure medications, will be recruited. Participants will be randomised to withdrawal of therapy and control arms and will undergo imaging investigations and cardiopulmonary exercise tests at baseline along with serum biomarker tests. Those participants randomised to withdrawal of therapy will have a gradual, supervised reduction of medications. If, at anytime, there are signs of recurring heart failure, medications will be restarted. Participants in the control arm will continue their medical therapy as usual.

Participants will be followed up with further biomarker testing, cardiopulmonary exercise testing and imaging investigations at 6 months.

The primary end-point will be a relapse in heart failure, defined by adverse remodelling, increase in left ventricular size, rise in serum biomarkers or clinical evidence of heart failure as judged by the clinical team.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Have an index diagnosis of heart failure confirmed by 2 independent operators based on clinical details.

2. Be currently taking at least 1 of the following medications loop diuretic, betablocker, angiotension converting enzyme inhibitor/angiotensin receptor blocker and mineralocorticoid receptor antagonist.

3. Have demonstrated evidence of left ventricular reverse remodelling following the initial diagnosis with subsequent improvement in ejection fraction to >50% and normalisation of left ventricular (LV) volumes.

4. Have no symptoms of heart failure (NYHA Class 1).

5. Low plasma NTproBNP.

Exclusion Criteria:

1. Uncontrolled hypertension.

2. More than moderate valvular disease.

3. Estimated glomerular filtration rate <30mls/min.

4. Atrial/supraventricular/ventricular arrhythmia requiring beta-blockade.

5. Pregnancy.

6. Unstable angina.

7. Age <16 years

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Withdrawal of therapy
Withdrawal of heart failure therapies (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, mineralocorticoid receptor antagonists and loop diuretics)

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart failure relapse	Defined by one of the following: 1) A reduction in left ventricular ejection fraction; 2) An increase in left ventricular size; 3) An increase in serum biomarker concentration from baseline; 4) Clinical evidence of heart failure	6 months
Secondary	Cardiopulmonary exercise testing with peak oxygen consumption	Change in peak oxygen consumption between baseline and follow-up test	6 months
Secondary	Quality of life	Patient questionnaires - Kansas City Cardiomyopathy Questionnaire and Heart Failure Symptom Questionnaire (symptom scores are calculated on the basis of the participants' answers to the questionnaires)	6 months
Secondary	Major adverse cardiovascular events (MACE) - safety end-point	MACE - unplanned cardiovascular (CV) hospitalisation, CV mortality and major adverse CV events (non-fatal myocardial infarction and non-fatal cerebrovascular accident)	6 months
Secondary	Percentage of participants with new and sustained arrhythmias	New and sustained arrhythmias diagnosed during follow-up	6 months
Secondary	Increase in left atrial volume as measured on cardiovascular magnetic resonance (CMR)	Increase in left atrial volume as measured on CMR (in millilitres)	6 months