ClinicalTrials.gov
ClinicalTrials.gov Menu

Perhexiline Therapy in Heart Failure With Preserved Ejection Fraction Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00839228
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:
Up to half of all patients with clinical features of heart failure are found to have normal heart pumping function. Recently the investigators have shown that a drug called perhexiline markedly improved exercise capacity and symptoms in patients with heart failure associated with impaired cardiac pump function. In this proposal the investigators will assess whether perhexiline has beneficial effects in patients with heart failure and a normal heart pumping function.

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Drug: Perhexiline Drug: Placebo Phase 2

Detailed Description:
Up to 50% of patients with symptoms of heart failure have a preserved left ventricular ejection fraction (HFpEF syndrome). Current therapy for systolic heart failure is targeted at inducing vasodilation and counteracting neuro-endocrine activation. There is a lack of a corresponding evidence base for the treatment of HEpEF. We have previously shown that perhexiline, an agent that increases the efficiency of energy production by shifting substrate utilization from free fatty acids towards glucose, was highly effective in improving exercise capacity, symptoms and cardiac function in patients with systolic heart failure. We have also recently shown that energy deficiency plays a major role in the pathophysiology of HFpEF. In this proposal we therefore aim to investigate the effectiveness of perhexiline in 70 HFpEF patients, in a 3 month randomised, double-blind, controlled trial. An interim analysis is planned after 20 patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Double Blind Placebo Controlled Trial of Perhexiline in Heart Failure With Preserved Ejection Fraction Syndrome (HFpEF)
Study Start Date : March 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Perhexiline
perhexiline 100mg o bd for 3 months
Drug: Perhexiline
100mg o bd for 3 months
Other Name: Pexsig

Placebo Comparator: Placebo
Placebo one tablet bd for 3 months
Drug: Placebo
Placebo one tablet bd for 3 months
Other Name: Starch Placebo




Primary Outcome Measures :
  1. Change in Peak oxygen consumption (Vo2max) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Symptomatic Status (Modified Minnesota Living with Heart Failure Questionnaire) [ Time Frame: 3 Months ]
  2. Resting myocardial energetics by cardiac MR spectroscopy (MRS) [ Time Frame: 3 months ]
  3. Resting and exercise diastolic function (nuclear studies) [ Time Frame: 3 months ]
  4. Indirect measures of resting LVEDP (tissue Doppler E/Ea) [ Time Frame: 3 months ]
  5. Global LV Ejection Fraction (MRI / nuclear studies) [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HFpEF will be defined as:

    • Clinical features consistent with heart failure
    • LVEF ≥ 50%, with no evidence of significant valvular disease
    • No hypertrophic cardiomyopathy, and no evidence of pericardial constriction
    • Peak VO2 < 80% predicted, with RER>1 and with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation)
  • Patients recruited will be in sinus rhythm

Exclusion Criteria:

  • BMI >35
  • Objective evidence of lung disease on formal lung function testing
  • Reversible myocardial ischaemia on contrast-enhanced myocardial stress Echocardiography, and no evidence of exercise-induced mitral regurgitation (>2+)
  • Impaired hepatic function; known hypersensitivity to perhexiline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839228


Locations
United Kingdom
University of Aberdeen
Aberdeen, United Kingdom, AB25 2ZD
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: Michael P Frenneaux, MBBS MD University of Aberdeen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT00839228     History of Changes
Other Study ID Numbers: RRK 3147
RRK 3147 ( Other Identifier: Research and Development )
MREC 08/H1207/84 ( Other Identifier: Ethics )
EudraCT 2006-001109-28 ( Registry Identifier: European Clinical Trials )
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: November 2015

Keywords provided by University of Aberdeen:
diastolic dysfunction
cardiac energetics
perhexiline
magnetic resonance spectroscopy

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Perhexiline
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents