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Assessment of Autonomic Dysfunction in Parkinsons Disease by Heart Rate Variability

Assessment of Autonomic Dysfunction in Parkinsons Disease by Heart Rate Variability: An Analytical Cross-Sectional Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/05/052285
Enrollment
130
Registered
2023-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G20- Parkinsons disease

Interventions

None listed

Sponsors

HBT Medical College Dr RN Cooper Hospital Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Heart rate variability to assess autonomic functions will be studied in 65 consecutive patients presenting with idiopathic PD according to the MDS-PD criteria, age 30-60 years visiting neurology outpatient department of Municipal General Hospital. Prior approval of ethics committee will be taken and informed consent obtained from the patients. Patients without any concomitant cardiovascular disease as confirmed by physical examination and normal 12-lead ECG will be included in the study.

Exclusion criteria

Exclusion criteria: Patients suspected of atypical/ secondary Parkinsonism as per MDS-PD criteria will be excluded from the study. Patients with dementia (as assessed by Mini Mental State Scale) that would affect their ability to provide consent and reliable self report will be excluded from the study. Patients with other medical conditions or co-morbidities or drugs as assessed by history, clinical examination and previous investigations known to affect autonomic nervous system or heart rate variability will be excluded from the study. 1. Atypical/ secondary Parkinsonism 2. Significant neurological disease such as stroke or epilepsy 3. Diabetes mellitus 4. Coronary artery disease / heart failure / myocardial infarction 4. Dyslipidemia, Hypertension 5. History of smoking/ alcohol intake 6. Broncho- pulmonary disease, dypnea. 7. Amyloidosis/ neuropathy 8.Patients who had medication known to influence autonomic system and biological rhythms will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
-To evaluate autonomic dysfunction in Parkinsons disease patients by linear and non-linear indices of short-term heart rate variability. Timepoint: 3 years

Secondary

MeasureTime frame
- To evaluate the predictive value of heart rate variability for autonomic dysfunction in Parkinsons disease by using Receiver operated curve (ROC).Timepoint: 3 years;To co-relate heart rate variability parameters with autonomic symptoms, duration and severity of disease, levodopa/levodopa equivalent dose in Parkinsons disease patients.Timepoint: 3 years

Countries

India

Contacts

Public ContactDr Mukta P Bidikar

NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

manishsawane@yahoo.co.in919822362835

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026