Brief Summary

Will metformin improve exercise capacity in chronic heart failure patients who has insulin resistance (pre-diabetic- means before they become diabetic)?

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

Completed

Started Aug 2007

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

May 15, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed

3 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed

4.2 years until next milestone

Results Posted

Study results publicly available

June 6, 2013

Completed

Last Updated

June 6, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

May 15, 2007

Results QC Date

January 14, 2013

Last Update Submit

May 28, 2013

Conditions

Congestive Heart Failure Insulin Resistance

Keywords

Chronic Heart FailureInsulin ResistanceMetforminPeak VO2

Outcome Measures

Primary Outcomes (1)

Peak VO2
Peak VO2 after 4 months of intervention with either metformin or placebo. The Mean difference between baseline and after 4 months was analyzed using t-test comparing metformin and placebo.
4 months

Secondary Outcomes (1)

Possible Mechanisms That Can Explain the Improvement of Exercise Capacity
4 months

Study Arms (2)

1

ACTIVE COMPARATOR

Receiving Metformin for 4 months

Drug: Metformin

2

PLACEBO COMPARATOR

Matched Placebo for 4 months

Drug: Matched Placebo (Capsules)

Interventions

MetforminDRUG

Started at 500mg bd for 2 weeks. If well tolerated, increase to 1000mg bd for 14 weeks

Matched Placebo (Capsules)DRUG

Similar dosing regime as active comparator

Eligibility Criteria

Age25 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients aged 25-80 yrs with compensated CHF in NYHA functional I-III with evidence of insulin resistance \[fasting insulin resistance index values of \> 2.7 are said to have insulin resistance\].
Documented Left ventricular systolic dysfunction or LV ejection fraction \< 35%

You may not qualify if:

Elderly patients (aged \>80 yrs);
Patients with decompensated CHF (NYHA functional class IV and /or signs of decompensated CHF);
Renal dysfunction (serum creatinine \> 160 mmol/L);
Patients who are unable to exercise including patients that will be excluded for reasons of safety or potential effects on exercise performance. Therefore, patients with angina or other cardiac or pulmonary symptoms potentially limiting exercise performance will be excluded.
Patients with underlying disease likely to limit life span and/or increase risk of interventions will be excluded i.e., cancer; cardiovascular disease .i.e., uncontrolled hypertension: SBP\>180 mmHg or DBP, recent stroke, any severe chronic disease (including renal and hepatic disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Dundeelead

Study Sites (1)

Medicine and Therapeutics, Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Publications (5)

Schiavone M, Gasperetti A, Vogler J, Compagnucci P, Laredo M, Breitenstein A, Gulletta S, Martinek M, Kaiser L, Tundo F, Palmisano P, Rovaris G, Curnis A, Kuschyk J, Biffi M, Tilz R, Di Biase L, Tondo C, Forleo GB; i-SUSI investigators. Sex differences among subcutaneous implantable cardioverter-defibrillator recipients: a propensity-matched, multicentre, international analysis from the i-SUSI project. Europace. 2024 May 2;26(5):euae115. doi: 10.1093/europace/euae115.
PMID: 38696701DERIVED
Schiavone M, Gasperetti A, Compagnucci P, Vogler J, Laredo M, Montemerlo E, Gulletta S, Breitenstein A, Ziacchi M, Martinek M, Casella M, Palmisano P, Kaiser L, Lavalle C, Calo L, Seidl S, Saguner AM, Rovaris G, Kuschyk J, Biffi M, Di Biase L, Dello Russo A, Tondo C, Della Bella P, Tilz R, Forleo GB; iSUSI investigators. Impact of ventricular tachycardia ablation in subcutaneous implantable cardioverter defibrillator carriers: a multicentre, international analysis from the iSUSI project. Europace. 2024 Mar 30;26(4):euae066. doi: 10.1093/europace/euae066.
PMID: 38584394DERIVED
Gasperetti A, Schiavone M, Ziacchi M, Vogler J, Breitenstein A, Laredo M, Palmisano P, Ricciardi D, Mitacchione G, Compagnucci P, Bisignani A, Angeletti A, Casella M, Picarelli F, Fink T, Kaiser L, Hakmi S, Calo L, Pignalberi C, Santini L, Lavalle C, Pisano E, Olivotto I, Tondo C, Curnis A, Dello Russo A, Badenco N, Steffel J, Love CJ, Tilz R, Forleo G, Biffi M. Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience. Heart Rhythm. 2021 Dec;18(12):2050-2058. doi: 10.1016/j.hrthm.2021.07.008. Epub 2021 Jul 14.
PMID: 34271173DERIVED
Cameron AR, Morrison VL, Levin D, Mohan M, Forteath C, Beall C, McNeilly AD, Balfour DJ, Savinko T, Wong AK, Viollet B, Sakamoto K, Fagerholm SC, Foretz M, Lang CC, Rena G. Anti-Inflammatory Effects of Metformin Irrespective of Diabetes Status. Circ Res. 2016 Aug 19;119(5):652-65. doi: 10.1161/CIRCRESAHA.116.308445. Epub 2016 Jul 14.
PMID: 27418629DERIVED
Wong AK, Symon R, AlZadjali MA, Ang DS, Ogston S, Choy A, Petrie JR, Struthers AD, Lang CC. The effect of metformin on insulin resistance and exercise parameters in patients with heart failure. Eur J Heart Fail. 2012 Nov;14(11):1303-10. doi: 10.1093/eurjhf/hfs106. Epub 2012 Jun 27.
PMID: 22740509DERIVED

MeSH Terms

Conditions

Heart FailureInsulin Resistance

Interventions

MetforminCapsules

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsDosage FormsPharmaceutical Preparations

Results Point of Contact

Title: Professor Chim C Lang
Organization: University of Dundee

Study Officials

Chim Lang, MD, FRCP
University of Dundee, Scotland
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Doctor

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 16, 2007

Study Start

August 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

June 6, 2013

Results First Posted

June 6, 2013

Record last verified: 2013-05

Locations

GB(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations