Recruiting

Observational Study

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT06289413

Conditions

Autonomic Dysfunction

Orthostatic Intolerance

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Development of AD/OI after BS

Study Details

Brief summary:

Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS.

Conditions

Autonomic Dysfunction

Orthostatic Intolerance

Study ID

NCT06289413

Start date

Feb 12, 2024

Status verified date

Oct, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between the age of 18 - 85 years
  • Can provide consent
  • Negative urine B-hCG
  • Continued follow-up with the bariatric surgery team.
  • BS includes one of the following: gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.
  • Phase I: Underwent BS within the last 3 years
  • Phase II: Will undergo BS within the next 3 months or underwent BS in the last 30 days

Exclusion Criteria:

  • Unable to provide consent
  • Pregnant or breastfeeding
  • BMI < 35
  • Revision surgery of one of the following BS from above
  • Prior history of autonomic dysfunction prior to BS
  • Developed AD 72 months post-procedure
  • No evidence of AD/OI

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Development of AD/OI after BS.

Interventions

Development of AD/OI after BS

OI is a type of AD that results in chronic supine-to-standing hypotension and disabling dizziness, lightheadedness, and even syncope. Whether arising from malabsorption, vagus nerve damage, or splanchnic vasodilation, the pathophysiology of OI in bariatric surgery is not clear and requires more investigation.

Treatment of OI usually consists of dietary and lifestyle changes, which may include compression stockings and abdominal binders. Medical options include peripheral vasoconstrictors and mineralocorticoids; some patients may be referred to Cardiology for further testing. Management is difficult and endurance and tilt training, inflatable abdominal bands, and beta-blockers have been proposed. One recent study demonstrated the treatment of refractory OI with Droxidopa. Yet, the success of treatment is individualized and necessitates more novel approaches.

Primary outcome measure

  • To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) [ Time Frame: 3 Months ]

Central Contacts and Locations

Central contacts

Locations

Menorah Medical Center

Recruiting

Overland Park, Kansas, United States, 66209

Bariatric and Metabolic Specialists

Recruiting

Overland Park, Kansas, United States, 66211

Kansas City Heart Rhythm Institute - Roe Clinic

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Principal Investigator:

Naga Venkata K. Pothineni, MD

Overland Park Regional Medical Center

Recruiting

Overland Park, Kansas, United States, 66215

Contacts

Principal Investigator:

Naga Venkata K. Pothineni

Centerpoint Medical Center Clinic

Recruiting

Independence, Missouri, United States, 64057

Centerpoint Medical Center

Recruiting

Independence, Missouri, United States, 64057

Research Medical Center Clinic

Recruiting

Kansas City, Missouri, United States, 64032

Contacts

Principal Investigator:

Naga Venkata K. Pothineni, MD

Research Medical Center

Recruiting

Kansas City, Missouri, United States, 64032

Contacts

Principal Investigator:

Naga Venkata K. Pothineni, MD

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Aug 28, 2025

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2025-08-28.