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Metformin + mHealth Intervention for Pulmonary Arterial Hypertension

Vanderbilt University Medical Center, Nashville, TN
Pulmonary Arterial HypertensionMetformin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing two interventions to see if they can improve insulin resistance in people with pulmonary artery hypertension. The primary endpoint is a 10% improvement in the distance the person can walk in six minutes, or an improvement in the person's functional class according to the World Health Organization.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
AZD3427 Dose A
1
LAM-001
1
Children ≥1 to <18 years old

Study Objectives

2 Primary · 37 Secondary · Reporting Duration: baseline and 12 weeks

baseline and 12 weeks
Change from baseline in six minute walk distance (meters)
Change from baseline to week 12 in World Health Organization Functional Class (WHO FC)
Week 12
Change from Baseline to week 12 in Daily Step Count Goal Attainment, as measured by the percentage (%) of subjects who meet their daily step count goal
Change from baseline in Estimated Right Ventricle (RV) and Right Atrial (RA) Pressure, as assessed by echocardiogram results, expressed in mmHg
Cerebral Ventricles
Change from baseline in Right Ventricle (RV) Free Wall Longitudinal Strain, as assessed by echocardiogram results, and expressed as percent (%) change in myocardial deformation.
Change from baseline in Right Ventricle (RV) and Left Ventricle (LV) Diastolic Function as assessed by Doppler inflow patterns on echocardiogram.
Change from baseline in Right Ventricle (RV) and Left Ventricle (LV) Ejection Fraction values as assessed by echocardiogram results, expressed in percentage (%).
Echocardiography
Echocardiography
Change from baseline to week 12 in Absolute Six-Minute Walk Distance (meters)
Change from baseline to week 12 in Body Mass Index (BMI)
Change from baseline to week 12 in Body Weight (kilograms)
Dyspnea
Change from baseline to week 12 in Daily Aerobic Time (minutes)
Change from baseline to week 12 in Daily Step Count, as measured by the mean daily step count
Change from baseline to week 12 in Emphasis-10 Quality of Life Survey Score
Change from baseline to week 12 in Homeostatic model assessment (HOMA)-Insulin Resistance (IR)
Change from baseline to week 12 in Patient Medication Regimen, as measured by percentage (%) of subjects with a change in medication regimen
Nesiritide
Change from baseline to week 12 in Quadriceps Skeletal Muscle Fatigue, as measured by total time to muscle fatigue during the muscle strength and function test
Change from baseline to week 12 in Quadriceps Skeletal Muscle Strength During the Muscle Strength and Function Test, as measured by maximum contraction strength
Triglycerides
Change from baseline to week 12 in RV Myocardial Muscle Triglyceride Content, as measured by % triglycerides
Change from baseline to week 12 in Resting Heart Rate (beats per minute)
Change from baseline to week 12 in Tricuspid Annular Plane systolic Excursion (TAPSE), expressed in mm.
Change from baseline to week 12 in quadriceps skeletal muscle contractile tissue cross-sectional
Change from baseline to week 12 in total daily activity assessed in step counts per minute
Dropout Rate Incidence
Number of participants with a change in Screening Clinical Characteristics
Number of participants with abnormal laboratory values of Plasma Acylcarnitine Profiles
Number of participants with abnormal laboratory values of Plasma Estradiol Metabolites
Number of participants with abnormal laboratory values of Plasma Free Fatty Acid Profiles
Number of participants with abnormal laboratory values of Plasma Lipid Profile
Number of participants with abnormal laboratory values of Urine Estradiol Metabolites
Number of patients with Treatment - Emergent Adverse Events (Safety and Tolerability of mHealth intervention and drug treatment in PAH subjects)
Number of patients with a PAH-related Hospitalization Incidence
Patient Satisfaction of treatment interventions, as measured by change in emphasis-10 survey score
baseline to/and 12 weeks
Incidence of Death

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
AZD3427 Dose A
2
LAM-001
2
Children ≥1 to <18 years old

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

4 Treatment Groups

Metformin + mHealth Intervention
1 of 4
Metformin + Usual Care
1 of 4
Placebo + mHealth Intervention
1 of 4
Placebo + Usual Care
1 of 4

Active Control

Non-Treatment Group

130 Total Participants · 4 Treatment Groups

Primary Treatment: Metformin + mHealth Intervention · Has Placebo Group · Phase 2

Metformin + mHealth InterventionActiveComparator Group · 2 Interventions: Metformin, mHealth Intervention · Intervention Types: Drug, Device
Placebo + mHealth InterventionPlaceboComparator Group · 2 Interventions: Placebo, mHealth Intervention · Intervention Types: Drug, Device
Placebo + Usual CarePlaceboComparator Group · 2 Interventions: Placebo, Usual Care · Intervention Types: Drug, Device
Metformin + Usual CareActiveComparator Group · 2 Interventions: Metformin, Usual Care · Intervention Types: Drug, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 12 weeks

Who is running the clinical trial?

The Cleveland ClinicOTHER
968 Previous Clinical Trials
1,361,127 Total Patients Enrolled
9 Trials studying Pulmonary Arterial Hypertension
1,438 Patients Enrolled for Pulmonary Arterial Hypertension
Vanderbilt University Medical CenterLead Sponsor
798 Previous Clinical Trials
639,278 Total Patients Enrolled
9 Trials studying Pulmonary Arterial Hypertension
2,383 Patients Enrolled for Pulmonary Arterial Hypertension
Mayo ClinicOTHER
3,007 Previous Clinical Trials
3,512,668 Total Patients Enrolled
11 Trials studying Pulmonary Arterial Hypertension
1,556 Patients Enrolled for Pulmonary Arterial Hypertension
Anna R Hemnes, MDPrincipal InvestigatorVanderbilt University Medical Center

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to walk on your own without assistance.
References

Frequently Asked Questions

Is the Metformin and mHealth Intervention combination a risk-free solution for patients?

"Despite no previous evidence of efficacy, the safety profile of Metformin + mHealth Intervention was rated a 2 due to some existing data indicating its security." - Anonymous Online Contributor

Unverified Answer

What objectives is this research endeavor attempting to accomplish?

"This clinical trial seeks to measure the efficacy of mHealth intervention or metformin in improving six minute walking distance and daily step count over a 12 week period. Secondary outcomes include an assessment of differences in participant characteristics including demographic information, current medication regimen, physical exam results, echocardiogram readings and laboratory values at baseline compared with those taken after completion of the treatment. Plasma Brain Natriuretic Peptide (BNP) will also be measured as it is a marker for myocardial stress which decreases with exercise training." - Anonymous Online Contributor

Unverified Answer

Is admission for participants currently available in this research program?

"According to clinicaltrials.gov, this research is still open for recruitment and has been regularly updated since it was first posted on August 23rd 2018. The most recent update occurred on June 27th 2022." - Anonymous Online Contributor

Unverified Answer

Has Metformin been combined with mobile health tools in past studies?

"Currently, 170 clinical trials studying the Metformin + mHealth Intervention are in operation. 43 of these investigations have progressed to Phase 3 and most them originate from Pittsburgh, Pennsylvania; though 1903 other medical sites are also conducting research into this therapy." - Anonymous Online Contributor

Unverified Answer

To what extent is participation in this medical experiment limited?

"Affirmative, the clinical trial remains open for enrollment. According to the data hosted on clinicialtrials.gov, this medical investigation was first posted on August 23rd 2018 and most recently updated on June 27th 2022; it is currently seeking 130 participants at a single location." - Anonymous Online Contributor

Unverified Answer

What conditions may be alleviated by the Metformin + mHealth Intervention combination?

"Metformin and a mHealth Intervention are two viable treatments for physical activity, type 1 diabetes mellitus, and diabetic ketoacidosis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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