Status:
COMPLETED
Neuromuscular Fatigue and Exercise Capacity in Patients With Type 2 Diabetes Mellitus and HFpEF
Lead Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Conditions:
Diabetes Mellitus, Type 2
Heart Failure Preserved Ejection Fraction
Eligibility:
All Genders
65-80 years
Brief Summary
An important feature of patients with HFpEF is impaired exercise tolerance, resulting in worsening and reduced quality of life. Studies in the literature on patients with HFpEF suggest that the limite...
Detailed Description
The progressive aging of the population of industrialized countries is accompanied by a dramatic increase in the prevalence of chronic diseases. Heart Failure (HF) is one of the major public health pr...
Eligibility Criteria
Inclusion
- Have a diagnosis of heart failure with preserved ejection fraction (\>50%, NYHA class II - III)
- Have an age between 65 and 80 years
- Be males
- Have at least one hospitalization for heart failure during the previous 10 years
- Have a diagnosis of diabetes for no more than 10 years at the time of cardiology examination
Exclusion
- 1\. Unstable diabetes documented by HbA1c ≥ 9%
- 2\. Significant additional valvular heart diseases
- 3\. Unstable heart failure
- 4\. Presence of a pacemaker or implanted defibrillator (AICD)
- 5\. Changes in drug therapy in the previous three months because of clinical instability
- 6\. Body mass index (BMI) \> 35 and \< 20 kg/m2
- 7\. Orthopedic limitations that prevent the exercise
- 8\. Presence of diagnosis and signs and symptoms of diabetic neuropathy (intensified perception of pain, burning or cold sensation, tingling, pins, and needles, hypo-hypersensitivity to touch)
- 9\. Severe deconditioning (patient is confined to home) or vigorous physical activity (sports or similar activity, estimated as more than two hours/day of vigorous exercise)
Key Trial Info
Start Date :
June 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06057623
Start Date
June 15 2023
End Date
April 30 2025
Last Update
July 30 2025
Active Locations (1)
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1
Istituti Clinici Scientifici Maugeri IRCCS
Lumezzane, Brescia, Italy, 25065