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A Pilot Feasibility Study in Recovered Heart Failure

NCT ID: NCT02859311

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Keywords

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Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Withdrawal of therapy

Gradual, supervised withdrawal of medical therapy over 4-16 weeks

Group Type EXPERIMENTAL

Withdrawal of therapy

Intervention Type DRUG

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

Control

Continuation of usually prescribed pharmacological therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Withdrawal of therapy

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjay Prasad, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton and Harefield NHS Foundation Trust

Locations

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Royal Brompton and Harefield NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Halliday BP, Vazir A, Owen R, Gregson J, Wassall R, Lota AS, Khalique Z, Tayal U, Jones RE, Hammersley D, Pantazis A, Baksi AJ, Rosen S, Pennell DJ, Cowie MR, Cleland JGF, Prasad SK. Heart Rate as a Marker of Relapse During Withdrawal of Therapy in Recovered Dilated Cardiomyopathy. JACC Heart Fail. 2021 Jul;9(7):509-517. doi: 10.1016/j.jchf.2021.03.010. Epub 2021 Jun 9.

Reference Type DERIVED
PMID: 34119469 (View on PubMed)

Halliday BP, Wassall R, Lota AS, Khalique Z, Gregson J, Newsome S, Jackson R, Rahneva T, Wage R, Smith G, Venneri L, Tayal U, Auger D, Midwinter W, Whiffin N, Rajani R, Dungu JN, Pantazis A, Cook SA, Ware JS, Baksi AJ, Pennell DJ, Rosen SD, Cowie MR, Cleland JGF, Prasad SK. Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial. Lancet. 2019 Jan 5;393(10166):61-73. doi: 10.1016/S0140-6736(18)32484-X. Epub 2018 Nov 11.

Reference Type DERIVED
PMID: 30429050 (View on PubMed)

Other Identifiers

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2015CD007B

Identifier Type: -

Identifier Source: org_study_id